SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation
SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation: 510(k) cleared for Fujifilm Corporation. Its amount of 156 is above the median of 138 (58th percentile). Dated 47 days ago, it serves as a historical benchmark. Score 42/100. As of 2026-11-03, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 156 · 58th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 9 related JP FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261229 |
| Device | SCENARIA View Phase 6.0 |
| Applicant | Fujifilm Corporation |
| Specialty / panel | Radiology |
| Product code | JAK |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-15 |
| Decision date | 2026-09-18 |
| Review time (days) | 156 |
| Third-party review | No |
| Applicant location | Minato-Ku, JP |
| amount percentile | 58th of 414 (median 138, 1.1x median) |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-18
- Data refreshed: 2026-11-03
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Top FDAPulse records (JP first): Lilium one (USM330) (K260605) · APERTO Lucent MRI System (K261283) · KOWA FM-600 (K261255) · DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece ( · TSK OptiXion (K262516) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation and 10 JP peers
- JP FDAPulse records like this one: 10
- SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation's amount: 58th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every JP peer: $2,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 156-day review, longer than typical.
What is the FDAPulse record for SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation?
SCENARIA View Phase 6.0 (K261229) by Fujifilm Corporation was cleared on 2026-09-18 after 156 days of review.
How does SCENARIA View Phase 6.0 (K261229): 510(k) cleared for Fujifilm Corporation compare to other FDAPulse records?
Its amount of 156 sits in the upper half (58th percentile) of 414 records; the median is 138. It is 47 days old; check the official source for later updates before acting.
SCENARIA View Phase 6.0 (K261229) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| SCENARIA View Phase 6.0 (K261229) | JP | 2026-09-18 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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